Adipokines in Obese Adolescents With Insulin Resistance: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Adipokines in Obese Adolescents With Insulin Resistance (NCT01410604), a randomized phase 4 study. The primary outcome is Adiponectin.

2. Clinical Question

The registry describes a controlled randomized clinical trial in obese adolescents with insulin resistance. The treatment comparison concerns the average change in adiponectin over the treatment period, rather than a comparison of values at a single follow-up point alone. The posted primary result contrasts the mean change in the metformin group with the mean change in the placebo group.

This is a question about a laboratory measure in a defined trial population. The registry record does not report enough information to assess how participants were recruited, how insulin resistance was defined, or whether the results apply to adolescents with different characteristics. The clinical importance of a change in adiponectin is also not established by the posted results. The statistical comparison describes the observed group means and their uncertainty; it does not by itself determine the meaning of that change for health or care.

3. Trial Design

The registry identifies NCT01410604 as a completed phase 4 randomized trial. Its title is “Adipokines in Obese Adolescents With Insulin Resistance,” and the official title describes inflammatory mediators following metformin treatment. The listed sponsor is Hospital Regional de Alta Especialidad del Bajio. The registry dates the study start to 2007-01 and primary completion to 2009-12.

The design is parallel group, with randomized allocation and quadruple masking. Participants were assigned to metformin or placebo. The metformin regimen was a 500 mg tablet by mouth every 12 hours, corresponding to a total dose of 1 g/day, for 3 months. The placebo regimen was a 500 mg oral tablet every 12 hours for 3 months. The record does not explain which people or roles were included in the quadruple masking, or describe the randomization sequence, concealment procedures, or whether masking was assessed.

Enrollment is listed as 31. Posted outcome summaries give mean changes for the primary measure in 12 participants in the metformin group and 14 in the placebo group. These are the counts attached to those outcome summaries; the registry does not explain their relation to enrollment or provide participant flow information. The adverse-event entries use separate at-risk counts, so they should not be taken as the outcome-analysis counts.

The primary endpoint was change in adiponectin from baseline to 3 months. The registry also lists fasting plasma glucose, fasting insulin, body mass index, and waist circumference as secondary outcomes. Four secondary outcomes have posted summary results in this record: fasting plasma glucose, fasting insulin, and body mass index are among them, while waist circumference has no posted result. The number of outcome measures is listed as 8, but full results for all measures are not included. Detailed protocol procedures, follow-up completeness, and the trial's prespecified statistical plan are not reported in the registry record.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

Reasons for not completing this period:

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as Adiponectin, measured over baseline and 3 months.

Adiponectin is a circulating adipokine, measured as a continuous serum concentration in µg/mL. The primary endpoint is the change from baseline after 3 months of treatment. A change score describes how much the measured value moved during follow-up, while the comparison between groups asks whether the average movement differed between assigned treatments.

Using a continuous measure preserves information about the magnitude and direction of individual values, rather than reducing the outcome to categories such as improved or not improved. The mean summarizes the average change within each group, and the standard deviation describes variation among observations around that group mean. These summaries help distinguish the average pattern from the variability among participants.

Adiponectin was selected as the primary measure in the registry record. The brief description frames the study as an examination of inflammatory cytokines and related mediators before and after metformin treatment. A laboratory concentration can be useful for examining biological response, but the registry does not state a clinically important threshold or explain how a particular change should be interpreted for an individual. Nor does the posted result establish that a change in adiponectin corresponds to a change in symptoms, complications, or other clinical outcomes.

The comparison is therefore best read as an estimate of the difference in average change between the metformin and placebo groups over the recorded follow-up. Interpretation also depends on how complete and reliable the measurements were, how missing observations were handled, and whether the analysis followed the planned method. Those details are not reported in the registry record.

7. Results Posted in the Registry

• Metformin: mean -0.71 versus -7.52 on control; difference 6.81 (95% CI 2.72 to 10.90), standardized effect d = 1.25; z-test p = 0.001.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Fasting Plasma Glucose

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Metformin: mean -1.08 versus 1.71 on control; difference -2.79 (95% CI -13.20 to 7.62), standardized effect d = -0.20; z-test p = 0.599.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Metformin and the control. The interval gives the range of effects that remain compatible with the data.

Fasting Insulin

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Metformin: mean -3.97 versus 11.03 on control; difference -15.00 (95% CI -30.17 to 0.17), standardized effect d = -0.79; z-test p = 0.053.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Metformin and the control. The interval gives the range of effects that remain compatible with the data.

Body Mass Index

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Metformin: mean -0.74 versus -0.71 on control; difference -0.03 (95% CI -0.68 to 0.62), standardized effect d = -0.04; z-test p = 0.928.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Metformin and the control. The interval gives the range of effects that remain compatible with the data.

The posted secondary outcomes cover fasting plasma glucose, fasting insulin, and body mass index, with waist circumference also listed as an intended secondary outcome. The mean differences and confidence intervals for the posted measures show a mixed pattern: estimates differ in direction and magnitude, and each reported interval includes zero. The fasting insulin estimate is closer to zero at one limit than the other measures, but its interval still includes zero. These results do not form a consistent pattern of clearly separated group means.

The secondary findings complement the primary adiponectin comparison by describing other metabolic and body-size measures over the same baseline-to-3-month period. They do not independently confirm the primary result, because each measure captures a different feature and has its own uncertainty. Nor does the primary adiponectin result establish a corresponding change in any secondary measure. The registry does not report a combined outcome or a formal analysis of relationships between these measures.

Unadjusted secondary results carry less weight when multiple outcomes are considered. In general, examining more outcomes increases the opportunity for chance findings, so inferential claims are stronger when the outcome family and adjustment approach are prespecified. The registry lists 8 outcome measures, but the record does not report a multiplicity procedure or a detailed testing hierarchy. The posted secondary p-values should therefore be read as individual unadjusted comparisons, not as a family-wise conclusion.

Absence of a confidence interval excluding zero is not proof that the groups are equivalent. An interval including zero can reflect uncertainty compatible with both modest differences and no difference, depending on its limits. Equivalence requires a prespecified margin and an analysis designed to test that question; neither is reported in the registry record. In addition, waist circumference and other listed outcome measures do not have posted results in this record, so the full secondary-outcome pattern cannot be assessed.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Fasting Plasma Glucose
• Fasting Insulin
• Body Mass Index
• Waist Circumference

9. Statistical Interpretation

10. Statistical Methods Explained

The registry reports means and standard deviations for continuous outcome changes. This choice describes both the average observed change and the spread of observations around that average. For each group, the mean gives a compact summary of the direction and magnitude of change. The standard deviation conveys how much participant-level values vary within the group; it is not the uncertainty of the mean and is not a confidence interval.

What does the mean difference represent?

The primary comparison is the mean change in the metformin group minus the mean change in the placebo group. A positive difference in this setting indicates that the metformin group's average change was higher, or less negative, than the placebo group's average change. The estimate of 6.81 µg/mL is in the same direction as the two posted group means, -0.71 µg/mL and -7.52 µg/mL. This is a between-group contrast, not the change within either group considered alone.

In general, comparing groups is preferable to interpreting a within-group change as evidence of a treatment effect. Both groups can change over time for reasons unrelated to assigned treatment, including natural variation, measurement conditions, or shared study procedures. Random allocation is intended to make treatment groups comparable on average, although the registry does not report the allocation procedure or enough information to assess balance in baseline characteristics.

How should a confidence interval be read?

In general, a confidence interval represents the uncertainty around an estimated quantity under the model and assumptions used to calculate it. The primary interval runs from 2.722 to 10.9 µg/mL. Its positive limits indicate that the interval does not include zero, the value corresponding to no mean difference. This does not mean that every plausible value is equally likely, and it does not state where individual participant responses fall.

A confidence interval also helps readers consider precision and magnitude together. A narrow interval would indicate greater precision than a broad interval, given the same scale and assumptions. The width of an interval should not be read as a measure of clinical importance. Clinical importance requires context about the outcome and a meaningful-change threshold; that threshold is not reported in the registry record.

What does the p-value add?

The primary comparison has an unadjusted p-value of 0.001. In general, a p-value measures how unusual results at least as incompatible with a specified null model would be if that model and the analysis assumptions held. It is not the probability that the observed result occurred by chance, nor the probability that a treatment is ineffective. It also does not measure effect size. The estimate and confidence interval are needed to understand direction and plausible magnitude.

The word “unadjusted” matters because the record lists multiple outcomes. A p-value calculated for one comparison does not automatically account for the possibility of examining several outcomes. The registry does not report a multiplicity adjustment or a prespecified hierarchy for interpreting outcome tests. Therefore the primary result can be described as posted, but the strength of any claim across a family of outcomes cannot be assessed from the record.

Why does variation matter?

The standard deviation reflects dispersion of participant measurements. Greater dispersion generally makes the group mean less precise for a given amount of information, while lower dispersion generally allows a more precise estimate. This is a general statistical relationship, not a claim that the registry's standard deviations have a particular cause. Biological heterogeneity, measurement error, and other factors can contribute to variability, and the record does not separate those sources.

When data are strongly skewed or contain influential extreme values, the mean and standard deviation may not fully describe the distribution. The registry does not provide distribution plots, participant-level observations, or diagnostic checks, so those features cannot be assessed. The posted comparison is a summary-statistic analysis, and its limitations should be considered alongside the small outcome-analysis counts.

What assumptions underlie the posted comparison?

Comparisons of means rely on assumptions about the data and the calculation of uncertainty. Common considerations include independent observations, an appropriate representation of within-group variability, and a suitable sampling distribution for the mean difference. General methods can accommodate unequal variances or non-normal data, but the registry record does not state which specific inferential procedure was used. The reported interval and p-value are therefore best described as posted results, rather than as independently verified calculations.

Randomized allocation supports a causal interpretation when the trial is conducted and analyzed as intended, but randomization alone does not resolve every concern. Loss to follow-up, deviations from assigned treatment, selective outcome reporting, or analysis choices can affect interpretation. Participant flow, adherence, protocol deviations, and analysis-population definitions are not reported in the registry record.

The registry has no reported analyses field entries for the posted secondary endpoints. This does not establish that no analyses were conducted; it means that analyses are not described in that part of the registry record. The record also does not state whether a statistical analysis plan was finalized before results were examined. These gaps make it difficult to determine whether the posted outcome definitions and analysis choices were prespecified.

For context, the planning illustration uses a normal approximation and assumes equal allocation, with a two-sided significance level of 0.05. Those assumptions describe the planning illustration, not the original trial design. The original sample-size justification and design assumptions are not reported in the registry record. A sample-size illustration based on the observed effect should not be mistaken for an assessment of whether the completed trial had adequate power before it began.

11. Confidence Intervals and Precision

The primary mean difference is 6.81 µg/mL, with a confidence interval from 2.722 to 10.9 µg/mL. The interval describes uncertainty in the estimated difference between group means under the method's assumptions. Because both limits are positive, the posted interval is consistent with a positive mean difference. It does not show the range of individual participant responses, and it does not imply that the true value is equally likely to be anywhere within the limits.

The group means are based on 12 participants for metformin and 14 for placebo. The reported standard deviations are 4.29 and 6.28, respectively. The standard deviations describe observed spread within groups, whereas the confidence interval describes uncertainty around the between-group estimate. These measures answer different questions and should not be substituted for one another.

Precision is limited by the amount of information in the outcome summaries and by the variability in the observed measurements. The interval still permits a range of possible magnitudes, even though it does not include zero. A statistically distinguishable mean difference is not necessarily large enough to matter clinically. The registry does not report a minimally important difference or a clinical threshold for adiponectin.

The posted record does not explain the analysis method, missing-data handling, or analysis population. These details can affect estimated uncertainty. The interval and p-value should therefore be understood as the registry's reported statistical summary, not as a complete account of all uncertainty surrounding the study.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning figures are participants per arm, not total events. The planning illustration assumes two-sided significance level 0.05, equal allocation between the two arms, and a normal approximation. It considers effects set at 100%, 75%, and 50% of the observed effect. The original trial's own sample-size assumptions and justification are not reported in the registry record.

The 80% power column gives the estimated number of participants per arm under those planning assumptions for a design with an 80% chance of detecting the stated effect if that effect were the true one and the model assumptions held. The 90% power column describes the corresponding planning target for a 90% chance. These are design calculations, not guarantees that a future study will produce a particular result. They do not determine the probability that the treatment effect is real.

The rows that plan for 75% or 50% of the observed effect consider smaller target effects than the row using 100% of the observed effect. Smaller effects are harder to distinguish from random variation, so they require more participants per arm to reach the same planned power under the stated assumptions. This relationship is general: a study designed to detect a more modest difference generally needs more information than one designed to detect a larger difference.

Because the planning calculation uses the observed effect from this trial, it is illustrative rather than a reconstruction of the original design. An observed effect can be unstable, especially when estimated from limited data. The figures are not observed power, and they should not be treated as an explanation of the trial's enrollment. The registry record does not report the trial's original sample-size rationale or its prespecified target effect.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = 6.810; pooled standard deviation σ = 5.459.
2. n = 2 × (1.96 + 0.842)² × 5.459² / 6.810² = 10.1, rounded up to 11 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- 6.81                      # observed difference in means
sigma <- 5.45872504955751                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(1410604)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 11 (80% power), 14 (90% power)
 75% of observed effect: n per arm = 18 (80% power), 25 (90% power)
 50% of observed effect: n per arm = 41 (80% power), 55 (90% power)
power.t.test: 11.1 
Simulated power at n = 11 per arm: 0.798 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

The registry lists 8 outcome measures, while the posted record includes the primary adiponectin result and summary results for several secondary measures. Testing or estimating multiple outcomes creates a multiplicity issue: in general, the chance of at least one apparently unusual result can increase as more outcomes are examined. This does not make any individual result invalid, but it affects how a collection of unadjusted p-values should be interpreted.

The primary outcome is identified as adiponectin, but the record does not describe a prespecified testing hierarchy, multiplicity adjustment, or family of hypotheses. It also does not report whether the primary endpoint and analysis were finalized before results were examined. A correction for multiplicity is not reported in the registry record. The primary p-value is therefore an unadjusted result, and the secondary p-values should not be treated as confirmatory evidence across all outcomes.

Missing-data handling is not reported in the registry record. The outcome summaries include 12 metformin participants and 14 placebo participants, while enrollment is listed as 31. The record does not explain the difference between enrollment and the available outcome counts, identify reasons for unavailable observations, or state whether any imputation or sensitivity analysis was used. It is not possible to determine from the posted summaries whether missingness could have influenced the estimates.

Analysis-population definitions are also not reported. The record does not say whether results use all randomized participants, participants who received treatment, participants with complete measurements, or another population. Treatment adherence, withdrawals, exclusions, and protocol deviations are not described in the posted record. Without these details, the extent to which the analysis preserves the benefits of randomized allocation cannot be assessed.

Interim analyses, stopping rules, and the complete statistical analysis plan are not reported in the registry record. This absence should not be interpreted as evidence that such procedures were or were not used. It means that readers cannot assess from this record whether the posted analyses follow prespecified decisions or how incomplete observations and multiple outcomes were handled.

15. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent serious adverse event terms

Serious events with the highest arm-level rate: epigastric pain (13.3%).

The registry lists serious adverse events for the metformin group with 15 participants at risk and 2 affected, and for the placebo group with 16 at risk and 1 affected. It also records 0 other adverse events in each group, using the listed at-risk counts of 15 and 16. These are registry counts and should be read separately from the outcome-analysis counts.

Epigastric pain is the top listed serious-event term, reported as 13.3%. The record does not provide enough detail to determine which group or groups contributed to that term, its timing, duration, severity beyond its classification as serious, or whether investigators considered it related to assigned treatment. The registry's adverse-event summary does not establish causation.

Deaths are not reported in the adverse-event entries. The record does not provide a fuller narrative of event definitions, monitoring, or how events were collected. Differences in listed counts should be interpreted cautiously, particularly because the at-risk denominators are small and the registry provides limited context. These figures describe recorded events; they do not by themselves establish the comparative safety profile of either assignment.

16. What the Result Does, and Does Not, Mean

The primary posted comparison shows a difference in average change in adiponectin between the metformin and placebo groups over 3 months. The metformin group's mean change was -0.71 µg/mL, compared with -7.52 µg/mL in the placebo group. The estimated mean difference was 6.81 µg/mL, and its confidence interval ran from 2.722 to 10.9. The unadjusted p-value was 0.001. In statistical terms, the reported interval and test are consistent with a positive difference in group averages.

That finding does not establish how meaningful the measured difference is for health. The registry does not report a clinically important threshold for adiponectin or evidence linking the observed change to a patient-centered outcome. The result is about a laboratory measurement, not a direct measure of symptoms, long-term health, or quality of life. It also does not show that every participant experienced a change in the direction of the group mean.

The secondary comparisons do not provide a uniform pattern of clear differences, and their unadjusted status calls for caution. They should not be used to claim that all measured metabolic or body-size outcomes changed in the same way as adiponectin. Nor does uncertainty in a secondary comparison demonstrate that the treatments are equivalent.

Randomization is a useful design feature for comparing assigned groups, but the record does not report participant flow, baseline characteristics, adherence, missing-data methods, or the analysis population. Those omissions limit assessment of whether the posted summaries reflect the original randomized groups and whether results are robust to missing observations or other analysis choices. The record also does not establish generalizability beyond the described population of obese adolescents with insulin resistance.

Accordingly, the most defensible interpretation is narrow: the registry reports a positive difference in mean adiponectin change between groups, with uncertainty quantified by the posted confidence interval. The statistical result does not by itself establish a mechanism, a clinical benefit, or a treatment recommendation. Such conclusions require evidence beyond these posted summary outcomes.

17. Why This Trial Matters Statistically

This trial illustrates why a statistical result should be read through its outcome definition, comparison, and uncertainty rather than through a p-value alone. The primary measure is a continuous laboratory outcome, and the key estimate is the difference in average change between randomized groups. Reporting the group means alongside the mean difference makes the direction of that contrast interpretable: the average change was less negative in the metformin group than in the placebo group.

The confidence interval adds information that a test result alone cannot provide. It shows the range of values compatible with the reported estimate under the analysis assumptions, while also making clear that uncertainty remains about the size of the difference. Readers can distinguish evidence that the group averages differ from evidence about whether the difference is clinically important; those are separate questions, and the registry does not supply a clinical threshold.

The record also demonstrates the importance of considering a family of outcomes. A study may measure several laboratory and body-size outcomes, but each additional comparison creates another opportunity for chance findings. Without a reported multiplicity plan, secondary p-values have a more exploratory interpretation. Likewise, an incomplete account of missing data and analysis populations makes it harder to judge the reliability of the posted estimates.

Finally, the planning illustrations show how assumptions about a target effect influence the amount of information needed for a future study. They are not evidence that the original study was designed around those assumptions. Separating planning calculations from the completed trial's observed results is essential: one describes hypothetical design requirements, while the other describes the data recorded for this trial.

18. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The record contains limited detail about how the trial was conducted and analyzed. Although it lists randomized allocation and quadruple masking, it does not describe the randomization method, allocation concealment, which roles were masked, or whether masking remained intact. Baseline characteristics and participant flow are not reported, so readers cannot assess group comparability, withdrawals, or the reasons the outcome summaries include 12 participants in one group and 14 in the other despite enrollment of 31.

Missing-data methods, adherence, protocol deviations, and analysis-population definitions are not reported in the registry record. These details matter because outcome availability and departures from assigned treatment can affect group comparisons. The registry also does not report the statistical analysis plan, the inferential procedure behind the posted intervals and p-values, or any sensitivity analyses.

The primary outcome is a laboratory measure, and the record gives no threshold for a clinically meaningful change. The posted estimate therefore describes a statistical difference in mean change, but its practical importance cannot be determined from the registry information alone. The secondary results are unadjusted, and a multiplicity plan is not reported. In addition, not all listed outcome measures have posted results in this record.

The sample-size illustration is based on the observed effect and stated planning assumptions, not on the original design rationale. The registry does not report the original target effect or sample-size justification. The adverse-event summary provides counts and a top serious-event term but little detail about timing, attribution, or event ascertainment. These limitations make it difficult to assess the completeness of outcome reporting, the robustness of the estimates, and how broadly the findings might apply.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Adipokines in Obese Adolescents With Insulin Resistance — NCT01410604.
• Registry record last updated 2012-04-27; status last verified 2012-04.
• Results first posted 2012-04-23.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

22. Record Summary

NCT01410604 is a completed, phase 4, randomized, quadruple-masked parallel-group trial sponsored by Hospital Regional de Alta Especialidad del Bajio. The registry lists enrollment of 31 and dates the study from 2007-01 to primary completion in 2009-12. The comparison was metformin, 500 mg orally every 12 hours, versus matching-dose oral placebo, with both assigned for 3 months.

The primary outcome was change in adiponectin from baseline to 3 months. The posted mean difference for metformin versus placebo was 6.81 µg/mL, with a confidence interval from 2.722 to 10.9 and an unadjusted p-value of 0.001. Secondary outcomes include fasting plasma glucose, fasting insulin, body mass index, and waist circumference; the record posts results for only some listed measures.

Important details about missing data, analysis populations, multiplicity, and the original sample-size rationale are not reported in the registry record. The results describe posted group summaries and should not be taken alone as evidence of clinical importance or as a basis for treatment decisions.